510(k) K234084
K234084 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products, Inc. for the device "STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count)". The FDA issued a decision of Substantially Equivalent on July 5, 2024. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Advanced Sterilization Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 5, 2024
- Date Received
- December 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type